Cisplatin-Vinorelbine Combination Chemotherapy in Locally Advanced Non-Small Cell Lung Cancer

1996 ◽  
Vol 82 (1) ◽  
pp. 57-60 ◽  
Author(s):  
Luciano Frontini ◽  
Paola Candido ◽  
Maria Teresa Cattaneo ◽  
Sabrina Zonato ◽  
Ernesto Piatto ◽  
...  

Aim The North Milan Group presents the results of a phase II study on a cisplatin-vinorelbine combination schedule in the treatment of locally advanced non-small cell lung cancer to evaluate its activity and tolerability. Methods Seventy-six consecutive patients entered the study. Patients’ characteristics were the following: males/females 69/7; median age, 61.4 years (range, 40-73); ECOG performance status, 0-1; 17 stage IIIa and 59 stage IIIb. There were 49 squamous cell carcinomas, 20 adenocarcinomas, and 7 large cell carcinomas. All patients had not been previously treated and showed measurable disease. Treatment consisted of vinorelbine, 25 mg/m2 on days 1 and 8, plus cisplatin, 80 mg/m2 on day 1, administered intravenously every 21 days for three standard courses. Results Seventy-four patients were evaluable for response. Objective responses were documented in 42/74 patients with an overall response rate (CR+PR) of 56.7%; 18/74 patients (24.3%) showed stable disease and the remaining 14/74 (18.9%) went into progression. Twelve patients (16.2%) were suitable for a subsequent surgery. The median duration of response was 13.3 months. Survival time ranged from 4 to 36 months: it was 14.6 months for PR patients, 8.6 months for NC and 5 months for PD. Mean survival time is presently 12.85 months (SE, 1.2 months). Toxicity evaluated on 222 cycles administered was acceptable, and it was necessary to use G-CSF or delay the treatment because of severe leukopenia in only a few cases. Conclusions The regimen is active and safe: the slight survival increase is likely due to the small amenability to surgery achieved (16.2%). However, our results are fully comparable to others obtained with vinorelbine in two/three drug combination chemotherapy regimens.

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 18135-18135
Author(s):  
G. Lee ◽  
K. Kim ◽  
Y. Cho ◽  
H. Kim ◽  
I. Hwang ◽  
...  

18135 Background: Combination chemotherapy with irinotecan and cisplatin is one of the standard treatments for patients with small-cell lung cancer (SCLC). In elderly patients, however, its efficacy and toxicity has not been well documented. In this Phase II study, we assessed the efficacy and toxicity of combination chemotherapy with irinotecan and cisplatin and examined whether advanced age compromises it in elderly patients with previously untreated extensive-disease small-cell lung cancer (ED-SCLC). Methods: In this study, 43 previously untreated elderly patients (65 years or older) with ED-SCLC were given combination chemotherapy consisting of irinotecan 60mg/m2 on days 1, 8 and 15 and cisplatin 60mg/m2 on days 1. The treatment was repeated every four weeks until patients completed the maximum six cycles. Results: Patients consisted of 34 men and 9 women, whose median age was 70 years (range 65 - 81 years). A complete response and a partial response were observed in 23.3% (10/43) and 58.1% (25/43), respectively. The overall response rate was 81.4% (95% C.I; 69.7 - 93.0%). The overall median survival was 10.3 months (range 7.8 - 12.7 months). The 1-year and 2- year survival rates were 31.8% and 3.4%, respectively. The median progression-free survival was 8.32 months (range 6.8 - 9.8 months). Major toxicities included neutropenia (grade 3 to 4, 55.9%), leukopenia (grade 3 to 4, 46.5%), infection (grade 3 to 4, 37.3%) and diarrhea (grade 3 to 4, 30.3%). Incidence of febrile neutropenia was significantly higher in patients with ECOG performance status 2 compared with ECOG performance 1 (70.7% vs. 5.2%; p < 0.001). There were two treatment related deaths in patients ECOG performance status 2. Conclusions: Our results indicate that combination chemotherapy with irinotecan and cisplatin is an effective treatment for elderly patients with ED-SCLC. However, physicians should be aware of the mortality and morbidity due to myelosuppression following this treatment in elderly ED-SCLC patients with ECOG performance status 2. No significant financial relationships to disclose.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 3072-3072
Author(s):  
Tatsuhiko Kashii ◽  
Toshiro Miwa ◽  
Shinya Kajiura ◽  
Ichiro Kinoshita ◽  
Satoshi Oizumi ◽  
...  

3072 Background: Polysaccharide-K (PSK, Krestin) is a protein-bound polysaccharide, extracted from cultured mycelium of Coriplus versicolor, and is associated with immunostimulatory activity. Although combination use of PSK with chemotherapy has been shown to prolong the response period in patients with small-cell lung cancer (SCLC), the efficacy of PSK in combination chemotherapy including cisplatin has been less examined. We examined safety and efficacy of combination therapy with cisplatin, irinotecan, and PSK in extensive-stage (ED) SCLC. Methods: Eligible pts included: histologically confirmed ED-SCLC without prior chemotherapy, age under 75 years, ECOG performance status ≤ 1, with evaluable disease and adequate organ function. Treatment: irinotecan 60 mg/m2 on days 1, 8, and 15 and cisplatin 60 mg/m2 on day 1 every 4 weeks for 4 to 6 courses, and oral PSK 3,000 mg/body daily. The treatment with PSK was continued after the end of cisplatin and irinotecan administrations, and was combined as a part of second-line therapy after exacerbations. Results: Between January 2008 and July 2010, 17 patients were enrolled, and the efficacy and prognosis were evaluated in 15 of 17 patients. Response rate was 66.6%, one-year survival rate was 66.6%, and two-year survival rate was 33.2%. The major toxicities were diarrhea and myelosuppression, and the common toxicity of PSK-containing combination chemotherapy was not observed. Conclusions: The combination chemotherapy with cisplatin, irinotecan, and PSK was effective and well tolerated in ED-SCLC. Clinical trial information: NCT00546130.


1994 ◽  
Vol 80 (6) ◽  
pp. 464-467 ◽  
Author(s):  
Paolo Lissoni ◽  
Sofia Meregalli ◽  
Vittorio Fossati ◽  
Franco Paolorossi ◽  
Sandro Barni ◽  
...  

Aims and Background The theraputic role of chemotherapy in advanced non-small cell lung cancer (NSCLC) is controversial because of its potentially detrimental action on host anticancer defenses. On the contrary, IL-2 would seem to prolong survival time by improving the immune status, even though it is generally less effective in determining tumor regression in NSCLC. Our previous studies have suggested the possibility of increasing tumor sensitivity to IL-2 by concomitant administration of immunomodulating neurohormones, such as the pineal hormone melatonin (MLT). On this basis, a study was carried out to evaluate the efficacy of immunotherapy with low-dose IL-2 plus MLT versus chemotherapy in advanced NSCLC. Methods The study included 60 patients with locally advanced or metastatic NSCLC, who were randomized to receive immunotherapy or chemotherapy. The immunotherapy consisted of IL-2 (3 million IU/day subcutaneously for 6 days/week for 4 weeks) and MLT (40 mg/day orally every day, starting 7 days before IL-2); in nonprogressing patients, a second cycle was repeated after a 21-day rest period, then they underwent a maintenance period consisting of one week of therapy every month until progression. Chemotherapy consisted of cisplatin (20 mg/m2) and etoposide (100 mg/m2)/day intravenously for 3 days; cycles of chemotherapy were repeated every 21 days until progression. Results No complete response was obtained. A partial response was achieved in 7/29 patients treated with chemotherapy and in 6/31 patients receiving chemotherapy. The difference was not significant. In contrast, the mean progression-free period and the percentage survival at 1 year was significantly higher in patients treated with immunotherapy than in those treated with chemotherapy. Toxicity was substantially lower in patients receiving immunotherapy than in those given chemotherapy. Conclusions This randomized study showed that immunotherapy with low-dose IL-2 plus MLT is a better tolerated and more effective therapy in terms of survival time than chemotherapy containing cisplatin in patients affected by advanced NSCLC.


2011 ◽  
Vol 07 (03) ◽  
pp. 174 ◽  
Author(s):  
Athanasios G Pallis ◽  

Non-small-cell lung cancer (NSCLC) accounts for approximately 85 % of all lung cancer cases. For patients with early-stage disease, surgery followed by adjuvant chemotherapy is the optimal treatment. For patients with locally advanced disease, the standard approach is chemoradiotherapy, since it offers a small but statistically significant prolongation in survival compared with the sequential approach. It should be noted, however, that this approach is associated with significant toxicity and it only applies to patients with good performance status. For patients with metastatic disease, chemotherapy represents the cornerstone of treatment and results in a median survival of approximately 10 months. Recently, the addition of bevacizumab or cetuximab to chemotherapy doublets and the use of gefitinib and erlotinib has improved the outcome in selected patients with advanced NSCLC. Hopefully, advances in understanding the molecular biology of cancer and mechanisms of tumourigenesis will facilitate the discovery and development of novel ‘targeted agents’ and will further improve outcomes for these patients.


1983 ◽  
Vol 1 (4) ◽  
pp. 247-250 ◽  
Author(s):  
T M Woodcock ◽  
M S Blumenreich ◽  
S P Richman ◽  
T T Kubota ◽  
P S Gentile ◽  
...  

Twenty-seven patients (25 males and 2 females) with histologically confirmed, unresectable, or metastatic non-small cell lung cancer were entered on a combination chemotherapy protocol including cisplatinum and vinblastine sulfate (DDP)(VLB). Patients had to have measurable disease as defined by the presence of two clearly measurable perpendicular diameters, be untreated with either chemotherapy or radiation therapy, and give informed consent to be eligible for study entry. The median age was 57 yr and the median performance status was 70 (Karnofsky scale); 10 patients had epidermoid carcinoma, 9 adenocarcinoma, 4 large cell carcinoma, and 4 undifferentiated carcinoma. All patients had intrathoracic disease, 12 also had extrathoracic lymph node involvement, 8 bone involvement, 2 liver metastasis, and 2 central nervous system metastasis prior to beginning chemotherapy; 9 patients had involvement of one site, 12 of two sites, 5 of three sites, and 1 of four sites. Cisplatinum was given as a short intravenous infusion of 120 mg/m2 on days 1 and 28, and then every 6 wk. Vinblastine was administered as an intravenous injection of 8 mg/m2 on days 1, 14, and 28, and then every 3 wk. Patients were evaluated prior to each course of cisplatinum. If progression occurred, therapy was discontinued. If stabilization or response was noted, then therapy was continued until intolerable toxicity or progression supervened. Every patient entered is considered evaluable for toxicity and response. There were no complete remissions; 14 patients achieved a partial response, 3 had a minimal response, 5 had stabilization of their disease, 1 had disease progression, and 4 are considered to have had drug deaths. Responses were seen after the first cisplatinum course in 13 patients and after the second in 1. Toxicities seen were universal nausea and vomiting; elevation of creatinine occurred in 6 patients, ranging from 2.1 to 14.6 mg/dl, and was clinically significant in 2 patients. Myelosuppression, with a leukocyte nadir of less than 3.0 X 10(9)l in 10 cases and platelet nadir of less than 100.0 X 10(9)l was seen in 5 cases and partial hearing deficit occurred in 2 patients. Median survival was 22 wk for the whole group (24 wk for the whole group if the 4 early drug deaths are excluded). Median survival was 26 wk for responding patients and 13 wk for nonresponding patients (remains the same if the early deaths are excluded from the latter group).(ABSTRACT TRUNCATED AT 400 WORDS)


2012 ◽  
Vol 08 (04) ◽  
pp. 208 ◽  
Author(s):  
Athanasios G Pallis ◽  

Non-small-cell lung cancer (NSCLC) accounts for approximately 85 % of all lung cancer cases. For patients with early-stage disease, surgery followed by adjuvant chemotherapy is the optimal treatment. For patients with locally advanced disease, the standard approach is chemoradiotherapy, since it offers a small but statistically significant prolongation in survival compared with the sequential approach. It should be noted, however, that this approach is associated with significant toxicity and it only applies to patients with good performance status. For patients with metastatic disease, chemotherapy represents the cornerstone of treatment and results in a median survival of approximately 10 months. Recently, the addition of bevacizumab or cetuximab to chemotherapy doublets and the use of gefitinib and erlotinib has improved the outcome in selected patients with advanced NSCLC. Hopefully, advances in understanding the molecular biology of cancer and mechanisms of tumourigenesis will facilitate the discovery and development of novel ‘targeted agents’ and will further improve outcomes for these patients.


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 18206-18206
Author(s):  
J. Tanaka ◽  
H. Yoshizawa ◽  
R. Ito ◽  
Y. Hayashi ◽  
H. Kuriyama ◽  
...  

18206 Background: Amrubicin (AMR) and paclitaxel (PTX) are promising agents for advanced non-small cell and small cell lung cancer (SC). However, the combination of these drugs for relapsed SC has never been reported. The aim of this study was to determine the maximum tolerated dose (MTD) of AMR and PTX, thus to investigate the recommended dose (RD) of this combination chemotherapy for relapsed SC patients. Methods: Relapsed SC patients after 1 or 2 regimens with age younger than 70 and good performance status (PS) were eligible. The treatment consisted of AMR (escalating from 30 to 40 mg/m2 by 5 mg/m2 increment) as a one- shot iv on days 1 through 3, and PTX (escalating from 70 to 90 mg/m2 by 10 mg/m2 increment) as a 60-minute infusion on days 4 and 11, repeated every 21 days. The dose-limiting toxicities (DLTs) were defined as grade 3/4 non-hematological toxicities, grade 4 thrombocytopenia, and grade 4 leukocytopenia / neutropenia for 4 days or more. Results: Nine relapsed SC patients were enrolled. All of them were sensitive-relapsed cases with mean age of 60.1 and PS of 0 - 1, and received one or more cycles of chemotherapy (mean: 2.7 cycles). Six patients were treated at level 1 (AMR 30mg/m2, PTX 70 mg/m2) with two of them on DLT of grade 4 neutropenia for 4 days or more. Three patients were treated at level 2 (AMR 35 mg/m2, PTX 70 mg/m2) with all of them on DLTs; grade 4 neutropenia for 4 days or more, grade 3 febrile neutropenia, and grade 3 pneumonia. Overall response rate was 63%. Conclusion: The MTD was identified to be level 2, and the RD for this regimen with AMR and PTX was considered to be 30 mg/m2 and 70 mg/m2, respectively. Treatment was well tolerated and the preliminary activity observed warrants further investigation. A phase II study is currently under investigation for relapsed and refractory SC patients. No significant financial relationships to disclose.


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